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FDA 510(k)

Precision Point Biopsy Needle Guide

K-Number: K160414 · 2016-08-01

ApplicantCorbin Clinical Resources, LLC
Decision Date2016-08-01
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Precision Point Biopsy Needle Guide is a medical device manufactured by Corbin Clinical Resources, LLC. It received FDA 510(k) clearance on 2016-08-01 under approval number K160414. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Precision Point Biopsy Needle Guide?

Precision Point Biopsy Needle Guide is a medical device that received FDA 510(k) clearance on 2016-08-01. It is manufactured by Corbin Clinical Resources, LLC. The 510(k) number is K160414.

When was Precision Point Biopsy Needle Guide approved by the FDA?

Precision Point Biopsy Needle Guide received FDA 510(k) clearance on 2016-08-01, under approval number K160414.

What company makes Precision Point Biopsy Needle Guide?

Precision Point Biopsy Needle Guide is manufactured by Corbin Clinical Resources, LLC.

What is the FDA product code for Precision Point Biopsy Needle Guide?

The FDA product code for Precision Point Biopsy Needle Guide is ITX.

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Other Devices by Corbin Clinical Resources, LLC

K160423Perineologic Access Needle

Related Devices (Code: ITX)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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